SKIN DEFENSE MAKEUP

Product NDC
68828-047
11-digit product format
688280047
Labeler code
68828
Product ID
68828-047_18abcbd7-0299-4c20-9fd7-317a988b891d
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE OCTISALATE OXYBENZONE
Dosage form
LOTION
Route
TOPICAL
Labeler
JAFRA COSMETICS INTERNATIONAL
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-04-24
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
6 g/100mL; g/100mL; g/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68828-047IInactivated by FDA2026-11-03
excluded packagepackage68828-04768828-047-67IInactivated by FDA2026-11-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68828-047-67IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68828-047-67IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68828-047-67IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68828-047-67IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68828-047-67IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68828-047-67IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68828-047-67IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68828-047-67IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68828-047-67IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68828-047-67IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68828-047-67IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68828-047-67IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68828-047-67IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68828-047-67IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68828-047-67IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68828-047-67IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68828-047-67IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68828-047-67IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68828-047-67IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68828-047-67IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68828-047-67IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68828-047-67EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68828-047-672020-01-31C16284748780-19d75b9d0-6b32-f424-e053-dadaa90a57ceSKIN DEFENSE MAKEUP SPF-15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-047-11SKIN DEFENSE MAKEUPSPF 1530 mL in 1 BOTTLELOTION301
68828-047-67SKIN DEFENSE MAKEUPSPF 151 in 1 BOXLOTION11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OCTISALATEACTIVE MOIETY4X49Y0596WSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
BIOSACCHARIDE GUM-1INACTIVE INGREDIENTBB4PU4V09HSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RASKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
CHONDRUS CRISPUSINACTIVE INGREDIENTOQS23HUA1XSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
DI-PPG-3 MYRISTYL ETHER ADIPATEINACTIVE INGREDIENTT32481VTXWSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7SKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
HYDROGENATED PALM GLYCERIDESINACTIVE INGREDIENTYCZ8EM144QSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)INACTIVE INGREDIENTJ2S07SB0YLSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
IPOMOEA MAURITIANA TUBERINACTIVE INGREDIENTK67Y2SGX79SKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
ISOPROPYL ISOSTEARATEINACTIVE INGREDIENTC67IXB9Y7TSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62SKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
MACROCYSTIS PYRIFERAINACTIVE INGREDIENTK31S3OG5C4SKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
METHYL METHACRYLATEINACTIVE INGREDIENT196OC77688SKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
OATINACTIVE INGREDIENTZ6J799EAJKSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
PEG-4 LAURATEINACTIVE INGREDIENTAYF4VM3N1ZSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
POLIDRONIUM CHLORIDEINACTIVE INGREDIENT6716Z5YR3GSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UTSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A2SKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
TAGETES ERECTA FLOWERINACTIVE INGREDIENTUH5X33P33ESKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
TREHALOSEINACTIVE INGREDIENTB8WCK70T7ISKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
UREAINACTIVE INGREDIENT8W8T17847WSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZSKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-047SKIN DEFENSE MAKEUP SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) LOTION [JAFRA COSMETICS INTERNATIONAL]1Legacy NDC, 2 package rows20120501_c57bce22-619e-43ab-875a-99821f82111f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68828-047-116882800471130 mL in 1 BOTTLE30 mlHistorical
68828-047-67688280047671 in 1 BOXHistorical